The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Emblaveo, intended for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections due to aerobic Gram-negative organisms in patients with limited treatment options.
AstraZeneca and Forest Laboratories, Inc. announced that ceftazidime/avibactam (CAZ-AVI) will enter phase III trials to investigate efficacy in treating hospitalised...
Actavis plc announced the FDA has approved Avycaz (ceftazidime-avibactam). Avycaz was approved for the treatment of adult patients with complicated...
AstraZeneca announced positive top-line results from RECLAIM-1 and RECLAIM-2 , the pivotal Phase III studies investigating the potential of the...
AstraZeneca has announced that the European Commission (EC) has granted marketing authorisation for Zavicefta (ceftazidime-avibactam, previously known as CAZ AVI),...
Allergan plc has announced the FDA has accepted for filing the company's supplemental New Drug Application (sNDA) for AvyCaz (ceftazidime...
Zavicefta is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1): • Complicated intra-abdominal infection (cIAI) • Complicated urinary tract infection (cUTI), including pyelonephritis • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Allergan announced the FDA has accepted for filing the company's supplemental New Drug Application (sNDA) for AVYCAZ (ceftazidime and avibactam),...
Allergan announced the FDA has approved the company's supplemental New Drug Application (sNDA) to update the label for AVYCAZ (ceftazidime...
The FDA has approved the supplemental New Drug Application (sNDA) to update the label for Avycaz (ceftazidime and avibactam), from...